Intuitive Surgical Careers
Manufacturing Engineering Manager
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 190057
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
Lead a team of Manufacturing Engineers in the creation and/or integration of efficient “mid-volume” manufacturing lines to produce surgical instruments used in minimally invasive robotically assisted surgery. This key technical management role will guide and mentor a talented product development and manufacturing organization in specifying and refining bill of materials (BOMs), work flow processes, supplier selection, assembly tooling design and detailed assembly / test instructions used to manufacture instruments while optimizing reliability, efficiency, capacity, and cost.
Roles and Responsibilities:
• Provide technical leadership for Core Instruments Manufacturing organization• Lead the manufacturing team and partner with other organizations to:
o Project manage product reliability improvements for Core Instruments from concept stage to final implementationo Identify, design, qualify, document and introduce assembly/test fixtures and equipment used in production.o Improve manufacturing process flows of core instrument manufacturing lines to optimize for reliability, efficiency, capacity and cost.o Manage the performance of manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans.o Material, process and supplier selection for components/sub-assemblies.o Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability and lead the implementation efforts for DFX changes.o Manage manufacturing strategy and production capability for Core Instrument lines to minimize customer backorders.o Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation.o Provide technical support for failure analysis and root cause investigation of product failures.• Provide administrative leadership / control for planning, staffing, budgeting, and project/program cost tracking for Core Instrument portfolio
• Establish group objectives and individual work goals consistent with overall product development goals:
o Assign tasks, set priorities, establish metrics and track progresso Assess employee performance and provide coaching to improve performance
Qualifications• Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary.• Provide budget estimates for product, process improvements, prototype materials, tooling and testing.• Work with Quality group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements.
• B.S. degree in engineering discipline, M.S. preferred
• Prior responsibility for validation/verification of processes, equipment and products.
• Strong technical analytical skills including (p)FMEA, tolerance analysis, and statistical methods
• Prior responsibility in decision making for component manufacturing processes (machining , injection molding & MIM, stamping, coining, extrusion)
• Familiar with mechanical CAD software (Solidworks).
• Good organizational skills. Ability to work on several fast-paced projects simultaneously.
• Prior experience with managing product, process changes is a plus
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
• Ability to motivate, guide, and inspire members of the core and extended project team. (technicians, purchasing, planning, engineering, regulatory, quality)
• Able to communicate effectively and professionally with customer, suppliers, and other people outside the company.
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
• Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.